PYG系列不銹鋼配液罐

本系列配液罐嚴(yán)格遵循《藥品生產(chǎn)質(zhì)量管理規(guī)范》GMP總則（1998年修訂版）第三十一、三十二條要求，根據(jù)GB150－98《鋼制壓力容器》，JB/T4735－97《鋼制焊接常壓容器》要求進行設(shè)計，制造驗收。

1、            容器保溫材料采用耐高溫、抗老化聚胺脂發(fā)泡或珍珠棉。

2、            接口采用通用標(biāo)準(zhǔn)ISO快裝卡盤式，內(nèi)膽選用進口不銹鋼SUS316L或SUS304制造，內(nèi)表面鏡面拋光至Ra≤0.28um，外表面拋光、鏡面、噴砂或冷軋原色亞光，符合GMP醫(yī)藥標(biāo)準(zhǔn)。

3、            攪拌器的密封采用進口衛(wèi)生級機械攪拌密封或磁力全密封攪拌裝置，攪拌轉(zhuǎn)速可任選。

4、            管口設(shè)有液位計口（靜壓式、電容式、無觸點式、超聲波式、玻璃管式）、空氣呼吸器、溫度計（數(shù)顯式或表盤式）、CIP清洗口、視鏡、防爆視燈（視鏡視燈一體化）、SIP滅菌口、進出液口及衛(wèi)生人孔等。

5、            容積有100L－10000L等規(guī)格，也可根據(jù)客戶實際需要進行設(shè)計、制造。

6、            隨機附著有關(guān)GMP驗證資料（含材質(zhì)報告、外購件合格證、驗證表格等）。

The liqukd arrangement tank strictly tallies with the 31^st and 32^nd clauses of 《Medicine Production Quality Management Norm》---GMP General Principles(1998Revised Edition),and is designed ,manuracturde and accepted according to the require-ments of GB150-98《Steel Welding Norma Vessel》.

1、                   Heat preservation material of the vessel adopts high-temperature resistant and anti-aging polyurethane blister or pearl cotton.

2、                   Joints adopt international general ISO package chuck,inner container adopts inported stainless steel SUS316l or SUS304,internal surface is polished to Ra≤0.28m,and external surface polishing mirror polish,sand blasting or cold-rolled nature-color surface polishing.All is in accordance with GMP medical standards.

3、                   Sealing of mixer adopts imported sanitation-grade mechanical stirring enchosing or magnetic totally-enclosed stirring device.The mixing rotary speed is optional.

4、                   Orifice is set with level gauge(static-pressure type,capacitance type,non-contact type,ultrasonic type and glass tube type),air respirator,thermometer(digital display type or dial plate type),CIP cleaning mouth ,viewing mirror,exlosion-proof viewing lamp(viewingmirror and viewing lamp integration),SIP sterilizing mouth,liquid entrance-exit gate and sanitary inlet.

5、                   Volume Specification:100L-10000L orto be designed and manufactured at customers ,actual request.

6、                   Relevant GMP testing data are attached in the machine.(including material report,external components cer-tificate of quality and verification form).

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